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Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-3)

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ClinicalTrials.gov Identifier: NCT02785042
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

Brief Summary:
This prospective, single-arm clinical multicenter study intends to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in Hispanic descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Heidelberg Spectralis OCT Not Applicable

Detailed Description:
This prospective, single-arm clinical multicenter study intends to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in Hispanic descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers; up to 10 study sites will recruit subjects. Overall an approximately equal age distribution from 18 to 90 years and an approximately equal number of females and males will be enrolled (approximately 40-60% females in each age group). All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit, if possible. Repeated perimetry or Spectralis scans may be performed at a second visit within 30 days of the initial visit. All examinations performed on the subjects are non-significant risk procedures.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 249 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-3)
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normal healthy volunteers
imaging with Heidelberg Spectralis OCT
Device: Heidelberg Spectralis OCT
OCT imaging




Primary Outcome Measures :
  1. Bruch-Membrane-Opening - Minimum Rim Width (µm) [ Time Frame: Baseline ]
    Bruch-Membrane-Opening - Minimum Rim Width (µm)

  2. Bruch-Membrane-Opening - Minimum Rim Area (µm^2) [ Time Frame: Baseline ]
    Bruch-Membrane-Opening - Minimum Rim Area (µm^2)

  3. Peripapillary Retinal Nerve Fibre Layer Thickness (µm) [ Time Frame: Baseline ]
    Peripapillary Retinal Nerve Fibre Layer Thickness (µm)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able and willing to undergo the test procedures, give consent, and to follow instructions.
  • Signed informed consent
  • Age ≥18 to 90.
  • Healthy eye without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve. Small drusen are acceptable in older subjects.
  • Hispanic decent (self-reported)
  • Negative history of glaucoma (not including family history)
  • Intraocular pressure ≤21mmHg.
  • Best corrected visual acuity ≥20/40.
  • Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
  • Axial length ≤ 26.0 mm (by optical biometry)
  • Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits or not abnormal visual field by judgment of the ophthalmologist / optometrist
  • Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. The optic disc is examined ophthalmoscopically and by evaluation of stereo photographs.
  • If both eyes are eligible, both eyes enter the study.

Exclusion Criteria:

  • Vulnerable subjects (as defined in ISO 14155 GCP) with the exception of employees of the site, and, if applicable, students of the respective university. Staff that is listed on the delegation form are excluded from participation.
  • Subjects unable to read or write
  • Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
  • Unusable disc stereo photos.
  • Inability to undergo the tests.
  • Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785042


Contacts
Contact: Thomas Schulz, PhD +49 6221 64630 thomas.schulz@heidelbergengineering.com

Locations
United States, California
University California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Linda Zangwill, MD         
Principal Investigator: Linda Zangwill, MD         
Assil Eye Institute Completed
Santa Monica, California, United States, 90404
North Bay Eye Associates Recruiting
Santa Rosa, California, United States, 95401
Contact: Jason Bacharach, MD         
Principal Investigator: Jason Bacharach, MD         
United States, Florida
Mid Florida Eye Center Clinic Recruiting
Mount Dora, Florida, United States, 32757
Contact: Gregory Panzo, MD         
Principal Investigator: Gregory Panzo, MD         
United States, Illinois
Illinois Eye Institute, Illinois College of Optometry Active, not recruiting
Chicago, Illinois, United States, 60616
United States, New York
SUNY College of Optometry Recruiting
New York, New York, United States, 10036
Contact: Mitch Dul, OD         
Principal Investigator: Mitch Dul, OD         
Ophthalmic Consultants of Long Island-Valley Stream Recruiting
Valley Stream, New York, United States, 11581
Contact: Gerard D'Aversa, MD         
Principal Investigator: Gerard D'Aversa, MD         
United States, Pennsylvania
Wills Eye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jay Katz, MD         
Principal Investigator: Jay Katz, MD         
Sponsors and Collaborators
Heidelberg Engineering GmbH
Investigators
Principal Investigator: Balwantray Chauhan, OD Department of Ophthalmology and Visual Sciences Dalhousie University

Responsible Party: Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier: NCT02785042     History of Changes
Other Study ID Numbers: S-2015-3-hi
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No